SUMMARY
Assemblers are primarily responsible for assembling and testing catheter-type medical
devices according to documented manufacturing procedures. The devices are assembled
using various manual UV bonding, heat fusing, and hand-soldering techniques. The
devices are assembled using Good Manufacturing Practices (performing line clearance,
following written procedures, completing manufacturing records) and Good Documentation
Practices.
The assembly work scope covers both Commercial and Pilot life cycles. Therefore, the
assemblers are expected to be flexible across process stations and product lines.
Additionally, assemblers are expected to learn quickly, offer feedback for process
improvements. Assemblers shall comply with documented company policies and
procedures, including quality, safety, and environmental policies.
PRINCIPAL DUTIES AND RESPONSIBILITIES
2.1 Clean workstations and perform line clearance per documented procedures.
2.2 Setup equipment and obtain materials as required by the manufacturing record.
2.3 Build subassemblies and/or final assemblies per manufacturing procedures.
2.4 Perform in-process inspections of components/materials, subassemblies, and final
assemblies to ensure that specifications are met and/or for data collection.
2.5 Record process and measurement data for quality control purposes, as required.
2.6 Monitor equipment parameters and results of in-process inspection(s).
2.7 Sign/date records to verify completion of procedures.
2.8 Assists supervisor and/or lead with inventory management.
EXPERIENCE REQUIREMENTS
3.1 A minimum of 3 years of medical device manufacturing or related experience.
EDUCATION REQUIREMENTS
High school diploma or equivalent.
OTHER QUALIFICATIONS
5.1 Able to assemble medical devices using adhesives, soldering iron, and hot box.
5.2 Able to assemble devices while using a microscope.
5.3 Able to read and understand written instructions